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Diss Factsheets
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EC number: 242-604-9 | CAS number: 18824-74-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 days dosing between gestation days 6 and 15
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data review as part of the US National Toxicity Program (NTP) and considered reliable.
Although testing performed on the acid form (the anhydride quickly hydrates to the acid on ingestion), the data is considered reliable with respect to simple salts such as potassium salt.
It is concluded that further animal testing cannot be justified
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- Treatment during day 6 - 15 by oral gavage at doses from 30 - 10 000 mg/kg
- GLP compliance:
- not specified
- Remarks:
- Study performed 1978
- Limit test:
- no
Test material
- Reference substance name:
- Tetrabromophthalic anhydride
- EC Number:
- 211-185-4
- EC Name:
- Tetrabromophthalic anhydride
- Cas Number:
- 632-79-1
- Molecular formula:
- C8Br4O3
- IUPAC Name:
- Tetrabromophthalic anhydride
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Although testing performed on the acid form (the anhydride quickly hydrates to the acid on ingestion), the data is considered reliable with respect to simple salts such as potassium salt.
Test animals
- Species:
- rat
- Strain:
- CD-1
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Not described as study comenced on Day 6 of gestation
- Duration of treatment / exposure:
- From Day 6 - 15 (10 treatment days)
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 30 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 3 000 mg/kg bw/day
- Dose / conc.:
- 10 000 mg/kg bw/day
- No. of animals per sex per dose:
- Five females per treatment level
- Control animals:
- not specified
Examinations
- Maternal examinations:
- Yes
- Ovaries and uterine content:
- Yes
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Death in four animals at 10000 mg/kg and greatly reduced bodyweight gain with anogenital staining
Parental NOAEL considered to be 3000 mg/kg/day - Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Death in four animals at 10000 mg/kg
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced body weight in surviving animals at 10 000 mg/kg
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- effects observed, treatment-related
- Description (incidence and severity):
- Subdued
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- not specified
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- not specified
- Other effects:
- not specified
- Details on maternal toxic effects:
- NOEAL 3000 mg/kg/day
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 3 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- clinical signs
- mortality
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Noting that maternal mortality was not taken into account
- Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- Noting that maternal mortality was not taken into account
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- No changes observed to the number of viable or non-viable foeti were observed. There were no compound related effects to resorptions, implantations or corpus lutea
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 3 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Highest treatment level without significant maternal toxicity
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- In common with this class of substance, thre was no reported teratogenic effects up to the maximum tolerated maternal treatment level.
- Executive summary:
Although testing performed on the acid form (the anhydride quickly hydrates to the acid on ingestion), the data is considered reliable with respect to simple salts such as potassium salt.
It is noted that treatment levels were far in excess of those permitted in modern studies in Europe and that in view of the parental toxicity reported, these high treatment levels were inappropriate.
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